To evaluate pharmacokinetic parameter of Vitamin E 400 mg capsules of Troikaa Pharmaceuticals Ltd India with Evion capsules 400 mg of Merck Sereno India in normal healthy adult human subjects

Not Applicable

Completed

• Registration Number: CTRI/2020/03/023718
• Lead Sponsor: Troikaa Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Subjects with Body Mass Index (BMI) 18.5 to 24.9 kg/m2 (both inclusive)

Subjects who are able to understand and willing to comply with the protocol requirements

Subjects who are able to understand willing to voluntarily provide written informed consent

Subjects who are able to understand and willing to adhere to protocol and the following study requirements

Should not consume xanthine containing products such as coffee tea chocolate or soft drinks at least 24 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) and until the last sample collection

Should not consume grapefruit or its products at least 7 days prior to dosing (i.e. in-house monitoring and the remaining based on history) and until the last sample collection

Subjects who are non-alcoholic, non-smokers and not consuming any tobacco products (based on history)

Exclusion Criteria

Subjects incapable of understanding and signing the informed consent document

Pregnant and lactating women (currently breast-feeding) Presence of pregnancy will be confirmed by Serum (β) Beta- hCG (Human Chorionic Gonadotropin) test before check-in

Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria at least 14 days prior to the first dose of study medication until the post-study follow-up. Use of hormonal contraceptives either oral or implants will not be acceptable

Subjects with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study

Subjects with abnormalities in resting heart rate ( >100 beats/min or <50 beats/min) and blood pressure either hypotensive episode (systolic blood pressure <90 mmHg or diastolic blood pressure <60 mmHg) or hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg) on the screening day

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of product in relation to the <br/ ><br>Rate of absorption, Extent of absorption <br/ ><br>Cmax AUC0-72Timepoint: -12.00 -6.00 hr -2 hr 0 hr 0.33 0.67 1.00 1.50 2.00 2.50 3.00 4.00 6.00 10.00 12.00 14.00 16.00 24.00 36.00 48.00 72.00

Secondary Outcome Measures

Name	Time	Method
Adverse events <br/ ><br>Laboratory abnormalities <br/ ><br>Tmax t1/2 KelTimepoint: -12.00 -6.00 hr -2 hr 0 hr 0.33 0.67 1.00 1.50 2.00 2.50 3.00 4.00 6.00 10.00 12.00 14.00 16.00 24.00 36.00 48.00 72.00